MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-H900; HAMILTON-H900 HUMIDIFIER

Catalog Number 950001

Device Problem Failure to Read Input Signal (1581)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

During examining the circuit by the partner technician, a corroded after part of the terminal on the left-hand side was found.Tube sets (left and right) were replaced.Device works now as intended.

Event Description

Hamilton medical ag received the following event description : an error message was displayed when connecting to the left-hand circuit.

• Brand Name: HAMILTON-H900
• Type of Device: HAMILTON-H900 HUMIDIFIER
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: ildem ustunkol ceylan ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 17018348
• MDR Text Key: 316093431
• Report Number: 3001421318-2023-02049
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 950001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1